A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment.

The core objective of post-market monitoring and vigilance is to enhance the well-being and safety of patients, healthcare professionals, users, and others by minimizing the occurrence of adverse events.

The monitoring of post-market performance aims to identify trends or issues that were previously undisclosed.

Custom-made medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). The TGA has changed the way of regulating custom-made medical devices in Australia, and the changes affect anyone who is manufacturing, importing, or supplying custom-made medical devices, including healthcare providers.

According to the Therapeutic Goods (Medical Devices) Regulations, 2002, a custom-made medical device is defined in the following terms:

The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices, Regulatory Affairs, and updated Regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.

The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Aside from the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.

Therapeutic Goods Administration (TGA), under the ‘Therapeutic Goods Act 1989,’ is entitled to regulate medical devices placed and marketed in Australia. Medical devices are regulated under the Therapeutic Goods (Medical Devices) Regulations, 2002. Initially introduced in 2002, the regulations underwent multiple amendments at a frequency of at least once a year, almost every year. Though these amendments introduced changes to accommodate the industry trends, a huge divide still exists between the industry and the regulations, triggering a major TGA medical device reform.  

The application of software technologies in varied healthcare management, including diagnosis or treatment of a disease condition, is accelerating at an unprecedented rate. The global medical device Authorities are revamping their regulations and guidelines to address these booming device technologies. In Australia, Therapeutic Goods Administration (TGA) is the Regulatory Authority responsible for the oversight of medical devices, including software and mobile applications.

Many Medical devices and Invitro Diagnostic (IVD) manufacturers gain market authorizations or device approvals in Australia using the conformity assessment certification issued by the EU Notified Bodies.

Below are the various factors affecting or impacting device registration in Australia.

In the context of COVID-19, there is an increasing interest in understanding the PPE regulations. To meet the growing interest, TGA the Australian Regulatory Authority has issued a guidance, which covers an overview of how PPEs are regulated, information for PPE manufactures and the PPE standards.

The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic. A lot of temporary changes have been made to the regulations of various medical, medicinal and cosmetic products, such as vaccines, PPE kits, surgical masks, hand gloves, hand sanitizers, etc., to expedite their approvals and market entry, and to meet their market demand.